Sclerotherapy Needle
FDA 510(k) K914496 · Surgitek Medical Engineering Corp.
510(k) numberK914496
Submission
- Device name
- Sclerotherapy Needle
- Applicant
- Surgitek Medical Engineering Corp.
Racine, WI, US - Received
- October 8, 1991
- Decision date
- December 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Other 510(k)s with product code FBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 05/29/2026SE |
| K253598 | InjecSURE Injection SystemFBK · Traditional | Carbon Medical Technologies, Inc. | 03/31/2026SE |
| K252021 | Disposable Endoscopic Injection NeedlesFBK · Traditional | Changzhou New Med Micro-Medtech Co., Ltd. | 12/02/2025SE |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…FBK · Traditional | Olympus Medical Systems Corporation | 10/16/2025SE |
| K241595 | EzVu Visual Vasopressor injector (EV-19)FBK · Traditional | Veol Medical Technologies Pvt , Ltd. | 02/27/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 10/04/2024SE |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | Laborie Medical Technologies, Corp. | 08/27/2024SE |
| K232200 | Disposable Injection NeedlesFBK · Traditional | Ningbo Xinwell Medical Technology Co., Ltd. | 04/12/2024SE |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…FBK · Traditional | Steris | 03/08/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/09/2023SE |
More from Zhejiang Soudon Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K914504 | Cytology BrushFDX · Traditional | 02/18/1992SE |
| K914495 | E.R.C.P. CatheterFGE · Traditional | 01/30/1992SE |
| K914497 | Biopsy ForcepsFCL · Traditional | 01/03/1992SE |
| K914505 | Stone BasketFFL · Traditional | 12/09/1991SE |
| K914503 | Grasping ForcepsOCZ · Traditional | 12/05/1991SE |
| K913928 | Surgitek(R) 4.5FR Lubri-Flex(Tm) Ureteral StentFAD · Traditional | 11/19/1991SE |
| K913294 | Surgitek(R) Laparoscopic Cholangiogram KitGCA · Traditional | 10/04/1991SE |
| K910769 | Surgitek(R) Ercp Contrast Media SystemODD · Traditional | 06/25/1991SE |
| K910768 | Surgitek(R) 420 CM G.I. Infusion GuidewireFGE · Traditional | 03/19/1991SE |
| K903127 | Surgitek(R) Turp MonitorGEI · Traditional | 10/09/1990SE |
Questions and answers
When was Sclerotherapy Needle cleared by the FDA?
Sclerotherapy Needle (K914496) received a 510(k) decision of Substantially Equivalent on December 5, 1991, 58 days after the submission was received.
What is the product code of K914496?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.